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Pharmaceutical QA Risk Manager

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: Negotiable
  • Job reference: 195484/008_1533819730
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 09/08/2018

Pharmaceutical QA Risk Manager

  • Pharmaceutical QA Risk Manager

  • Greater Boston Area


A global Kidney care focused pharmaceutical/medical device company is looking for a Pharmaceutical QA Risk Manager to join their rapidly expanding team! This company is known for being a leading in dialysis healthcare globally. Now is a pivotal time to get in with this group as the Pharmaceutical QA Risk Manager will have the ability to lead and impact the pharmaceutical QA group as the company continues to build out their pharmaceutical division of the organization.

The Pharmaceutical QA Risk Manager will have the following responsibilities:

The Pharmaceutical QA Risk Manager will be responsible for taking ownership of the risk management process as a whole. The individuals focus will own the process from risk assessments to risk control and then finding the possible solutions.

  • Conduct Risk Assessments

  • Determine Risk Control and find possible solutions

  • Ensure documents are properly maintained, with good documentation practices, for all manufactured distributed products, quality system processes, and applicable solutions.

  • Collaborate with other teams

  • Remain current with industry standards and best practices to promote activities necessary for the evolution of the Pharmaceutical Risk Management System

The ideal candidate will have the following skill set:

  • Bachelor's degree in science, engineering, quality management, technical, or healthcare related field

  • Minimum of 5+ years experience in quality systems

  • Strong knowledge of ICH Q9

  • Excellent communication skills

  • Hands on risk management experience within pharmaceuticals

Compensation:

  • Excellent Salary + excellent bonus + excellent benefits

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